BioFire Diagnostics, LLC: BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- BioFire Diagnostics, LLC
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Reason / hazard
- Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
- Recall initiated
- 2025-10-22
- Code info
- UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
- Product quantity
- 97 Kits (2,910 pouches)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Salt Lake City
- State
- UT
- Country
- United States
- Event id
- 97870
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